OFFICIAL-SOURCE RECALL · AUSTRALIA
High Filtration Surgical Face Masks with Ties Level 3 Recall: Classification Class II Reason for the Action
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- High Filtration Surgical Face Masks with Ties Level 3
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Why this product was recalled
Classification Class II Reason for the Action The Therapeutic Goods Administration (TGA) conducted a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). Med-Con Pty Ltd was found to have supplied four batches of their Mask, surgical, single use, which failed the TGA's fluid resistance tests at level 3. The fluid resistance test measures the mask's ability to protect against the penetration of blood and/or body fluids, as outlined in the Australian Standard: AS 4381:2015. Updated 29/07/2026: The affected batches will be recalled. Instructions for Customers/Users Customers are advised to quarantine the affected batches. TGA and Sponsor are still investigating, and further information will be provided once the investigation is complete. Updated 29/07/2026: Customers are to return the affected batches as outlined in the customer letter. Action Commencement Date 29/07/2026 Responsible Entity Med-Con Pty Ltd
Hazard
Classification Class II Reason for the Action The Therapeutic Goods Administration (TGA) conducted a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). Med-Con Pty Ltd was found to have supplied four batches of their Mask, surgical, single use, which failed the TGA's fluid resistance tests at level 3. The fluid resistance test measures the mask's ability to protect against the penetration of blood and/or body fluids, as outlined in the Australian Standard: AS 4381:2015. Updated 29/07/2026: The affected batches will be recalled. Instructions for Customers/Users Customers are advised to quarantine the affected batches. TGA and Sponsor are still investigating, and further information will be provided once the investigation is complete. Updated 29/07/2026: Customers are to return the affected batches as outlined in the customer letter. Action Commencement Date 29/07/2026 Responsible Entity Med-Con Pty Ltd
Official recall notice
High Filtration Surgical Face Masks with Ties Level 3
Agency: Therapeutic Goods Administration
Official publication date: July 29, 2026
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